Study Stopped
The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
STABILIZE-CKD
A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on CKD Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
2 other identifiers
interventional
1,112
21 countries
276
Brief Summary
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate \[eGFR\] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
276 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2024
CompletedResults Posted
Study results publicly available
January 8, 2026
CompletedJanuary 8, 2026
December 1, 2025
2.4 years
September 1, 2021
February 12, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total eGFR Slope (Coprimary Analysis #1)
Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)
Baseline (Maintenance phase) to visit 17 (week 69)
Chronic eGFR Slope (Coprimary Analysis #2)
Chronic eGFR slope, 12 weeks to visit 17 (week 69)
12 weeks to visit 17 (week 69)
Secondary Outcomes (3)
Incidence of the Composite of Kidney Failure Outcomes
From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
Incidence of RAASi Reduction
From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
UACR
At visit 13 (week 24)
Study Arms (2)
Sodium Zirconium Cyclosilicate (SZC)
EXPERIMENTALSZC 5 g every other day to 15 g once daily + Lisinopril/Valsartan
Placebo
PLACEBO COMPARATORPlacebo + Lisinopril/Valsartan
Interventions
Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets. During Maintenance Phase: \- Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water.
Tablet for oral administration. Unit dose strength: 2.5, 5, 10 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.
Tablet or capsule for oral administration. Unit dose strength: 40, 80 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.
Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily. The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved.
Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets. During Initiation Phase: * S-K \> 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water. The 10 g SZC single dose should be administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L); the total daily dose is 30 g SZC. * S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours. During Run-in and Maintenance Phases: \- Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water.
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol
- Must be ≥ 18 years of age at the time of signing the informed consent.
- Must have eGFR ≥ 25 and ≤ 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1)
- Must have UACR ≥ 200 and ≤ 5000 mg/g as calculated by central laboratory at screening (Visit 1). If the first sample does not fulfil eligibility criteria, a second sample can be obtained during the screening period; if so, the UACR measurement from the second sample must be within the eligibility range.
- Any of the following criteria, a or b, at screening (Visit 1):
- Cohort A: Hyperkalaemia (S-K \> 5.0 to ≤ 6.5 mmol/L) as measured by the central laboratory, and on adequate\* or limited\*\* RAASi therapy due to hyperkalaemia.
- Cohort B: Normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L) as measured by the central laboratory and on limited\*\* RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as:
- (i) Participants with a previous medical history or record of hyperkalaemia within the prior 24 months, who are on limited\*\* RAASi therapy despite indication in CKD.
- (ii) Participants in whom RAASi therapy is indicated in CKD, who are on limited\*\* RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L.
- (iii) Participants in whom RAASi therapy has been discontinued or reduced to suboptimal\* doses because of hyperkalaemia.
- \*Adequate RAASi dose levels are defined in protocol; doses lower than these are considered as suboptimal.
- \*\*Limited RAASi therapy is defined as no or suboptimal RAASi therapy according to dosing guidance provided in protocol.
- If on thiazide or loop diuretics, the dose must have been stable for 2 weeks prior to screening (Visit 1).
- If on RAASi therapy, the dose must have been stable for one month prior to screening (Visit 1) and remain stable during screening.
- If on an SGLT2i treatment (ie, dapagliflozin and canagliflozin), finerenone, or any other medications in these 2 classes that are approved for CKD, the dose must have been stable for 3 months prior to screening (Visit 1).
- +1 more criteria
You may not qualify if:
- New York Heart Association class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure.
- Myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 3 months prior to screening (Visit 1).
- Participants with a known history of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg within 2 weeks prior to screening (Visit 1) are excluded. In addition, any participant with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg as measured at screening (Visit 1) and confirmed by repeated measurement is excluded. Participants may be rescreened once blood pressure is controlled.
- QTcF \> 550 msec at screening (Visit 1).
- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome.
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted.
- Lupus nephritis or anti-neutrophil cytoplasmic antibody-associated vasculitis.
- Change in renal function requiring hospitalisation or dialysis within 3 months prior to screening (Visit 1).
- History of renal transplant (or anticipated need for renal transplant during the study).
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- History of hereditary or idiopathic angioedema.
- Any prior hypersensitivity to ACEi or ARB that in the investigator's judgment precludes use of lisinopril and valsartan/irbesartan. Prior hypersensitivity reactions to consider include, but are not limited to, development of angioedema, icterus, hepatitis, or neutropaenia or thrombocytopaenia requiring treatment modification.
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- Any condition outside the CV and renal disease area such as, but not limited to, malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgment.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (276)
Research Site
Surprise, Arizona, 85374, United States
Research Site
Tucson, Arizona, 85741, United States
Research Site
Canyon Country, California, 91351, United States
Research Site
Chula Vista, California, 91910, United States
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Northridge, California, 91324, United States
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San Dimas, California, 91773, United States
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South Gate, California, 90280, United States
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Tarzana, California, 91356, United States
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Denver, Colorado, 80230, United States
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Boynton Beach, Florida, 33435, United States
Research Site
Hialeah, Florida, 33012, United States
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Lauderdale Lakes, Florida, 33313, United States
Research Site
Ocoee, Florida, 34761, United States
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Temple Terrace, Florida, 33637, United States
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Nampa, Idaho, 83687, United States
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Chicago, Illinois, 60643, United States
Research Site
Oak Brook, Illinois, 60523, United States
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Fort Wayne, Indiana, 46804, United States
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Louisville, Kentucky, 40205, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02115, United States
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Flint, Michigan, 48532, United States
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Saint Clair Shores, Michigan, 48081, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64111, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12205, United States
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Great Neck, New York, 11021, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45267, United States
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Bethlehem, Pennsylvania, 18017, United States
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Chester, Pennsylvania, 19013, United States
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Columbia, South Carolina, 29203, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37404, United States
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Arlington, Texas, 76015, United States
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Fort Worth, Texas, 76164, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77099, United States
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San Antonio, Texas, 78212, United States
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Newport News, Virginia, 23606, United States
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Buenos Aires, ARG 1425, Argentina
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Buenos Aires, C1429BWN, Argentina
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CABA, C1440AAD, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600, Argentina
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Rosario, 2000, Argentina
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San Vicente, 5006, Argentina
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Sarandí, B1872EEC, Argentina
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Curitiba, 80440-020, Brazil
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Fortaleza, 60115282, Brazil
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Joinville, 89227-680, Brazil
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Maringá, 87060-040, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90160-093, Brazil
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São Paulo, 04039-000, Brazil
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São Paulo, 05403-9000, Brazil
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Blagoevgrad, 2700, Bulgaria
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Botevgrad, 2140, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Gorna Oryahovitsa, 5100, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lom, 3600, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4001, Bulgaria
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Plovdiv, 4004, Bulgaria
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Samokov, 2000, Bulgaria
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Sandanski, 2800, Bulgaria
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Silistra, 7500, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 3700, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Yambol, 8600, Bulgaria
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Saint John, New Brunswick, E2L 4L2, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Baotou, 014010, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100044, China
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Beijing, 100191, China
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Beijing, 102206, China
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Beijing, 102218, China
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Changchun, 130041, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400010, China
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Guangzhou, 510000, China
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Guangzhou, 510062, China
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Guangzhou, 510180, China
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Guangzhou, 510630, China
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Guiyang, 550002, China
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Hangzhou, 310014, China
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Hefei, 230601, China
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Hengyang, 421001, China
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Huizhou, 516001, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanjing, 210029, China
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Ningbo, 315010, China
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Sanya, 572000, China
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Shanghai, 200025, China
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Shanghai, 200040, China
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Shanghai, 201199, China
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Shanghai, 201210, China
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Shantou, 515041, China
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Shengyang, 110004, China
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Shenyang, 110001, China
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Shenzhen, 518036, China
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Taiyuan, 030012, China
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Ürümqi, 830054, China
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Wuhan, 430010, China
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Wuhan, 430060, China
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Wuxi, 214023, China
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Xi'an, 710061, China
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Xuzhou, 221000, China
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Yantai, 264000, China
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Yinchuan, 750004, China
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Zhengzhou, 450052, China
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Zhuzhou, 412007, China
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Coimbatore, 641018, India
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Kolkata, 700020, India
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Madurai, 625107, India
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New Delhi, 110029, India
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Bari, 70124, Italy
Research Site
Bassano del Grappa, 36061, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Messina, 98125, Italy
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Pavia, 27100, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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San Giovanni Rotondo, 71013, Italy
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Verona, 37126, Italy
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Amagasaki-shi, 660-8550, Japan
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Atsugi-shi, 243-0035, Japan
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Chiba, 260-8712, Japan
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Chuo-shi, 409-3898, Japan
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Chūōku, 103-0002, Japan
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Chūōku, 104-8560, Japan
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Fukuoka, 814-0180, Japan
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Kamakura-shi, 247-0056, Japan
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Kanoya-shi, 893-0015, Japan
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Kasugai-shi, 486-8510, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kawasaki-shi, 211-8510, Japan
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Kitakyushu, 805-8508, Japan
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Kitakyushu-shi, 802-8555, Japan
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Koriyama-shi, 963-8052, Japan
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Koshigaya-shi, 343-8555, Japan
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Kumamoto, 861-8520, Japan
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Kure-shi, 737-0023, Japan
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Marugame-shi, 763-8502, Japan
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Matsumoto-shi, 390-8621, Japan
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Matsusaka-shi, 515-8557, Japan
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Matsuyama, 790-8524, Japan
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Nagoya, 457-8511, Japan
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Nagoya, 466-8650, Japan
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Naka, 311-0113, Japan
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Noda, 278-8501, Japan
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Osaka, 543-8922, Japan
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Osaka, 559-0012, Japan
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Ōita, 870-0033, Japan
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Ōmihachiman, 523-0082, Japan
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Sakaishi, 593-8304, Japan
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Takarazuka-shi, 665-0873, Japan
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Toyota, 470-0396, Japan
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Toyota-Shi, 471-8513, Japan
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Tsu, 514-8507, Japan
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Tsuchiura-shi, 300-0028, Japan
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Urayasu-shi, 279-0021, Japan
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Yaizu-shi, 425-8505, Japan
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Yokohama, 227-8501, Japan
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Yokohama, 234-0054, Japan
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Yokohama, 236-0004, Japan
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Yonago-shi, 683-8605, Japan
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Alor Star, 5460, Malaysia
Research Site
Batu Caves, 68100, Malaysia
Research Site
Johor Bahru, 80100, Malaysia
Research Site
Kajang, 43000, Malaysia
Research Site
Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Seri Manjung, 32040, Malaysia
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Cuauhtémoc, 06700, Mexico
Research Site
Culiacán, 80230, Mexico
Research Site
Guadalajara, 44670, Mexico
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Mazatlán, 82000, Mexico
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Mérida, 97070, Mexico
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Mérida, 97130, Mexico
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México, 03100, Mexico
Research Site
México, 06700, Mexico
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San Luis Potosí City, 78250, Mexico
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Veracruz, 91900, Mexico
Research Site
Davao City, PH-8000, Philippines
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Iloilo City, 5000, Philippines
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Krakow, 31-156, Poland
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Lodz, 92-213, Poland
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Poznan, 61-485, Poland
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Rzeszów, 35-055, Poland
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Tczew, 83-110, Poland
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Ponce, 00717, Puerto Rico
Research Site
Aramil, 624002, Russia
Research Site
Moscow, 123182, Russia
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Perm, 614000, Russia
Research Site
Rostov-on-Don, 344022, Russia
Research Site
Saint Petersburg, 191167, Russia
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Almería, 4009, Spain
Research Site
Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 8003, Spain
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Getafe, 28905, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lugo, 27004, Spain
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Madrid, 28040, Spain
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Santa Cruz de Tenerife, 38010, Spain
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Seville, 41009, Spain
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Valencia, 46010, Spain
Research Site
Valencia, 46014, Spain
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Hualien City, 97002, Taiwan
Research Site
Kaohsiung City, 81362, Taiwan
Research Site
Kaohsiung City, 82445, Taiwan
Research Site
Kaohsiung City, 833, Taiwan
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Keelung, 20448, Taiwan
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New Taipei City, 220216, Taiwan
Research Site
New Taipei City, 23561, Taiwan
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Taichung, 40201, Taiwan
Research Site
Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
Research Site
Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 114, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Chaingmai, 50200, Thailand
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Hat Yai, 90110, Thailand
Research Site
Ratchathewi, 10400, Thailand
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Adapazarı, 54100, Turkey (Türkiye)
Research Site
Ankara, 06230, Turkey (Türkiye)
Research Site
Ankara, 06340, Turkey (Türkiye)
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Ankara, 6230, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
Research Site
Kahramanmaraş, 46100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Dnipropetrovsk, 49005, Ukraine
Research Site
Kharkiv, 61039, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 03057, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04053, Ukraine
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Lutsk, 43005, Ukraine
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Vinnytsia, 21028, Ukraine
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Zaporizhzhia, 69001, Ukraine
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Zhytomyr, 10002, Ukraine
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Biên Hòa, 810000, Vietnam
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Da Nang, 55000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Research Site
Huế, 530000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early due to recruitment challenges (not safety concerns). The ensuing small number of fully evaluable subjects (716 randomized vs planned 1360) and short follow up (mean 8 - 9 months vs planned 24 months) had a heavy negative impact on the formal statistical analyses, especially slope analyses, and therefore preclude any meaningful conclusions on eGFR slopes.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn M. Chertow, MD, MPH
Stanford University School of Medicine, Stanford, CA USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 24, 2021
Study Start
September 30, 2021
Primary Completion
February 7, 2024
Study Completion
February 7, 2024
Last Updated
January 8, 2026
Results First Posted
January 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.